Registering surgical suture materials (surgical threads, needles, ligatures, fixing elements) is a strictly regulated procedure requiring confirmation of biocompatibility, sterility, and clinical safety. Elibrium offers a detailed action plan for successful completion of all stages.
Step1: Determine the Class and Code of the Product Suture materials belong to Class IIa or IIb (depending on absorbability and duration of tissue contact). It is essential to correctly determine the OKPD code and the type of medical device according to Roszdravnadzor's nomenclature classification. An error at this stage leads to rejection of documents.
Step2: Preparation of Technical Documentation A complete package is assembled:
- Technical Specifications (TS) describing composition, thread geometry, mechanical properties (strength, elasticity).
- Instructions for Use (for sterile products – indicating storage conditions and shelf life).
- Information on raw materials: polymers (polyglycolide, polydioxanone, polypropylene, etc.), dyes, coatings.
- Data on the production process and quality control (sterilization, packaging).
- Results of preliminary tests (e.g., knot strength, biodegradation).
Step3: Mandatory Testing Tests are conducted in accredited laboratories:
- Toxicological – for cytotoxicity, sensitization, irritation, pyrogenicity.
- Microbiological – sterility testing and preservative effectiveness (if applicable).
- Clinical (or functional) – to confirm safety and efficacy in surgical use (often at specialized medical institutions).
Step4: Submission of Application and Documents to Roszdravnadzor The package is submitted via the Unified Register of Medical Devices (ERMI). It includes:
- Application and document inventory.
- Technical specifications, instructions, test protocols.
- Declaration of conformity (if required).
- Payment documents for state duty.
Important: All documents must be in Russian, with notarized translations for foreign manufacturers.
Step5: Expert Review and Interaction with the Authority Roszdravnadzor conducts an expert review of quality, safety, and efficacy (up to50 working days). Requests for dossier revisions or additional data may occur. At this stage, Elibrium promptly prepares justified responses and corrections.
Step6: Obtaining the Registration Certificate After a positive decision, a perpetual certificate is issued, granting the right to produce, import, and sell the suture material in the Russian Federation. The product is then entered into the State Register of Medical Devices.
How Elibrium Simplifies the Registration Process We provide a full range of services:
- Consultation on product class and code selection.
- Development and revision of technical documentation.
- Selection of accredited testing centers and timeline control.
- Management of dealings with Roszdravnadzor: application submission, expert review support, handling inquiries.
- Legal support in contentious situations.
Contact Elibrium – we make suture material registration fast, transparent, and efficient. Details on our website or via company contacts.
